NCT01026415

Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients With CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations).

Conditions

• Carcinomas
• Disease, Hodgkin
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Neoplasms

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	1.8 mg/kg IV every 21 days
DRUG	rifampin	600 mg/day PO
DRUG	midazolam	1 mg IV
DRUG	ketoconazole	400 mg/day PO
DRUG	brentuximab vedotin	1.2 mg/kg IV every 21 days

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-12-04
• Last updated: 2014-12-18

Locations

6 sites across 1 country: United States